Label: WALGREEN ANTICAVITY WHITENING- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 19, 2011

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  • KEEP OUT OF REACH OF CHILDREN


  • USE

    Helps protect against cavities.

  • WARNINGS

    As with all fluoride toothpaste, keep out of reach of children under 6 years of age.  If you accidentally swallow more than used for brushing, seek professional help or contact the Poison Control Center immediately.

  • Directions

    Adults and children         Brush teeth throughly, preferably after
    2 years and older              each meal, or at least twice a day, or as
                                               directed by your dentist. Do not swallow.

    Children under                    To minimize swallowing, use a pea-     
    6 years of age                    sized amount and supervise brushing
                                                until good habits are established.

    Children under 2 years     Ask a dentist or physician.

  • Inactive Ingredients:

    Sorbitol, Water, Hydrated Silica, PEG-6, Sodium Lauryl Sulphate, Alcohol (1.14%), Flavor, Xanthan Gum, Carbomer, Sodium Benzoate, Titanium Dioxide, Tetrasodium Pyrophoshate, Sodium Saccharin, Triclosan, Blue 1, Yellow 4.

  • PRINCIPAL DISPLAY PANEL

    image of container

  • Active Ingredient

    Sodium Fluoride 0.243% (0.15% w/v fluoride ion)...Anticavity toothpaste

  • PURPOSE


  • INGREDIENTS AND APPEARANCE
    WALGREEN ANTICAVITY WHITENING  
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0634
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Alcohol (UNII: 3K9958V90M) .0114 g  in 1 g
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINT (Minty Fresh) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0634-05181.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/11/2009
    Labeler - Walgreen (008965063)
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